The U.S. Food and Drug Administration (FDA) has released its final rule “Substances Generally Recognized as Safe” (due for publication on August 17, 2016). Under the Federal Food, Drug, and Cosmetic Act, GRAS substances are not considered “additives” and so do not require FDA premarket review. The rule — criticized by consumer advocacy groups such as the Environmental Working Group, Consumers Union and the Center for Science in the Public Interest — formalizes FDA’s voluntary GRAS (Generally Recognized as Safe) notification system for substances added to food and eliminates the voluntary GRAS affirmation petition. A consent decree entered in a case brought by the Center for Food Safety required FDA to issue a final rule by August 31 of this year. The rule contains provisions applicable to human food and to animal feed.

The rule does not attempt to introduce fundamental procedural changes or significant innovations to GRAS analyses. Beyond eliminating the GRAS affirmation petition process, FDA focuses on clarifying further the criteria for concluding a substance is GRAS (FDA will no longer use the phrase “GRAS determination”). GRAS notification will remain entirely voluntary, and FDA has not acceded to the wishes of commentators asking the agency to establish mandatory registration of “private” (i.e., un-notified) GRAS conclusions. Basic principles remain the same, with FDA reiterating that, for example:

• “General recognition of safety” requires common knowledge throughout the qualified scientific community that the substance is reasonably certain not be harmful under its intended use (identical to the food additive standard)
• Establishing that a substance is GRAS through scientific procedures requires using generally available and accepted scientific data, information or methods, which ordinarily are published (as well as generally accepted scientific procedures)

FDA received numerous comments on the proposed rule. One of the most controversial areas relates to determining what data, information or methods are “generally available” and the weight other information (i.e., private) will be given. GRAS notifiers, under the final rule, must specify which data and information provided to FDA they consider generally available (and which not). Every GRAS notification must explain “how there could be a basis for a conclusion of GRAS status if qualified experts do not have access to such data and information,” though FDA will continue to accept non-peer reviewed information and unpublished sources. Finally, perhaps of greatest interest to the heads of Regulatory Affairs departments, GRAS submissions will now be required to bear a signed certification that the GRAS notice is complete, representative and balanced, including both favorable and unfavorable pertinent information.

FDA has promised to release a new guidance document on the final rule in the near future.